Chemoperfusion for Mesothelioma

Recruiting in Palo Alto (17 mi)

Overseen byBela Kis, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma (MPM).

Research Team

Bela Kis, M.D., Ph.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

Adults with malignant pleural mesothelioma (MPM) that's not removable by surgery or those who refuse surgery. They must have tried and not responded to standard chemotherapy, or refused it. Participants need to be in good enough health for the treatment, not pregnant or breastfeeding, willing to use contraception, and able to follow study procedures.

Inclusion Criteria

I can do most activities by myself without help.

I am a woman who is either not able to have children, past menopause, or willing to use birth control during and after the study.

Ability to understand and the willingness to sign a written informed consent document

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Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

I haven't had chemotherapy in the last 4 weeks or I've recovered from its side effects.

I am allergic to certain chemotherapy drugs but not to IV contrast media.

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Treatment Details

Interventions

Cisplatin (Anti-tumor antibiotic)
Gemcitabine (Anti-metabolites)
Methotrexate (Anti-metabolites)

Trial OverviewThe trial is testing a procedure called transarterial chemoperfusion using drugs cisplatin, methotrexate, and gemcitabine. It aims to find out if this method is safe and effective for treating MPM when delivered directly into arteries feeding the tumor.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Chemoperfusion + QuestionnaireExperimental Treatment4 Interventions

Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.

Cisplatin is already approved in Canada, Japan for the following indications: